Details for New Drug Application (NDA): 204644
✉ Email this page to a colleague
The generic ingredient in IMATINIB MESYLATE is imatinib mesylate. There are thirty-four drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the imatinib mesylate profile page.
Summary for 204644
Tradename: | IMATINIB MESYLATE |
Applicant: | Mylan |
Ingredient: | imatinib mesylate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 204644
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 204644 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2245 | 0378-2245-77 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2245-77) |
IMATINIB MESYLATE | imatinib mesylate | TABLET;ORAL | 204644 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2246 | 0378-2246-93 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2246-93) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Jun 21, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
Approval Date: | Jun 21, 2017 | TE: | AB | RLD: | No |
Complete Access Available with Subscription